FDA Adverse Event Malfunction Summary report: N

PREMICATH PICC

MDR report key: 4820873 · Received June 3, 2015

Report

Report Number: 2245270-2015-00050
Event Type: Malfunction
Date Received: June 3, 2015
Date of Event: February 28, 2015
Report Date: June 3, 2015
Manufacturer: VYGON GMBH
Product Code: LJS
PMA / PMN Number: K041468
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

AT THIS MOMENT, VYGON CONTINUES TO INVESTIGATE THE COMPLAINT BUT IS UNABLE TO DETERMINE A ROOT CAUSE. THIS INCLUDES, BUT IS NOT LIMITED TO, INVESTIGATION OF THE RAW MATERIAL AND RAW MATERIAL DEVELOPMENT, THE MANUFACTURING PROCESS OF THE CATHETER, AND STERILIZATION. THERE HAS BEEN NO CHANGE TO ANY MATERIAL OR PROCESS. IT IS UNDETERMINED AT THIS TIME IF THE PRODUCT IS NON-CONFORMING, OR IF THE CAUSE IS A RESULT OF CLINICAL USE. MOVING FORWARD, VYGON WILL BE USING A SIMILAR MARKET CLEARED MATERIAL FOR ALL PREMICATH CODES. THIS MATERIAL IS CURRENTLY ONLY USED IN PREMICATH 1261.20G CLEARED UNDER K954302. THIS MATERIAL HAS A GREATER TENSILE STRENGTH AND PERFORMS BETTER IN CONJUNCTION WITH THE USE OF ORGANIC SOLVENTS USED FOR SITE PREP. THIS MATERIAL IS ALREADY FULLY VALIDATED FOR USE IN ALL CATHETER CODES AS ALL CATHETERS ARE IDENTICAL, THE ONLY DIFFERENCE BEING THE COMPONENTS OF INSERTION.

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED TO VYGON FOR EVALUATION AND COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.

Description of Event or Problem · 1

VYGON PREMICATH 28GA PICC LINE WAS INSERTED INTO PT, AND THEN DISCOVERED TO HAVE A HOLE IN THE CATHETER. THERE WAS NO APPARENT HARM TO THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357200	PREMICATH PICC	LONG-TERM INTRAVASCULAR CATHETER	LJS	VYGON GMBH	1261.203G	14D25

Patients

Seq	Age	Sex	Outcome	Treatment
1